Prescription drug · NDA
Pylarify Truvu (Piflufolastat f-18) NDC 85347-001
Piflufolastat f-18 120 mCi/mL · Injection · Intravenous · Aphelion LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85347-001-01 | 85347000101 | 50 mL in 1 VIAL, GLASS (85347-001-01)Marketed from Jul 1, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Pylarify Truvu
- Generic name (nonproprietary)
- piflufolastat f-18
- Active ingredients
- Piflufolastat f-18 — 120 mCi/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Aphelion LLCNDC labeler code 85347
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 220089
- Marketing start
- Listing expires
- Other FDA classes
- Positron Emitting Activity (Mechanism)
- Identifiers
- Product ID 85347-001_558f7e93-a905-767a-e063-6294a90a1527SPL ID 558f7e93-a905-767a-e063-6294a90a1527SPL set ID 121c1cb8-6f60-4644-a775-b81c6f21d812UNII 3934EF02T7
- Pharmacologic class
- Radioactive Diagnostic Agent
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N485347000101followed by a unit qualifier and the quantityPackage 85347-0001-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
PYLARIFY TRUVU is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level PYLARIFY TRUVU is a radioactive diagnostic drug indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level ( 1 )…
Excerpt only. Read the full label for complete information.
About NDC 85347-001
- What is NDC 85347-001?
- 85347-001 is the product NDC for Pylarify Truvu (piflufolastat f-18), Piflufolastat f-18 120 mCi/mL injection, listed with the FDA by Aphelion LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pylarify Truvu (Piflufolastat f-18).
- What is the active ingredient?
- Piflufolastat f-18.
- Who is the labeler?
- Aphelion LLC, NDC labeler code 85347. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pylarify Truvu?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.